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Adventitious Agents / Virology Testing

When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is required according to the ICH guidelines. We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materials and final products, including:

In-vitro adventitious virus assay

Porcine and bovine adventitious virus assay

A range of assays addressing specific contamination risks also is available

Contact us to speak to our experts to discuss your in vitro testing requirements.

There is a wide range of Virology testing service available to ensure production of biologicals is free from contamination, including:

Virology Testing (adventitious virus) We perform a series of biosafety assays designed to detect species specific adventitious viruses in master cell banks, working cell banks, virus seed stock, raw materials, unprocessed bulk and final products.

Each assay method is fully validated in accordance with ICH Q2 (R1) guidelines. Assays are available for human viruses, bovine viruses, porcine viruses, simian viruses, canine, murine and many more. Development and validation services also are available for emerging viruses.

Our expert team performs quantitative PCR tests designed to detect adventitious and endogenous viruses in cell banks, virus seed stock, raw materials and final products. We have a variety of assays available globally for:

human viruses

respiratory viruses

porcine viruses

bovine viruses

simian viruses

canine viruses

murine and many more specific target PCRs.

Our dedicated and experienced virology team is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample integrity for PCR detection of adventitious virus.

Retrovirus Testing Services

Retroviruses can integrate into the host genome making them difficult to detect by normal methods. Retroviruses may also remain later in the cell genome, and therefore require specific methods for detection.

Co-cultivation of production cells at the limit of the in vitro age is an assay we offer to test for latent retroviruses for our clients. Essentially, your production cells are plated along with susceptible cell lines that exhibit stronger phenotypic CPE when the virus enters them. Thus, viruses that are expressed as non-infectious particles or exhibit low level of expression in production cells are detected.

We perform in vivo assays designed to detect adventitious and endogenous viruses in cell banks, virus seed stock, raw materials and final products.

A major concern when using mammalian cell lines for production of a biotechnology product or biological is the risk of contamination by endogenous and adventitious viruses, which can occur during the manufacturing process. Such contamination could have serious clinical consequences detrimental to the patient. Our in vivo virus detection services are available to ensure the absence of human and animal adventitious viruses in your biologicals.

Electron microscopy services provide high-resolution images of viral or biological specimens at an ultrastructural level to detect the presence, absence, and quantitation of microbial or adventitious agents in biological fluids or in cell substrates. We provide GMP-compliant transmission electron microscopy (TEM) services for ultrastructural pathology and viral particle identification, tabulation, quantification and characterization in support of the FDA Points to Consider (PTC) documents.

We offer a variety of assay options for your electron microscopy needs including: